e-BioMatrix PostMarket Registry (eBMX-PMR)

May 3, 2019 updated by: Biosensors Europe SA

A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5652

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Universität Innsbruck
      • Vienna, Austria
        • AKH der Stadt Wien
      • Vienna, Austria
        • KFJ - Hospital Vienna
      • Vienna, Austria
        • Krankenanstalt Rudolfstiftung
  • Czechia
      • Brno, Czechia
        • Teaching Hospital Brno
      • Usti nad Labem, Czechia
        • Masaryk Hospital Usti nad Labem
  • Denmark
      • Roskilde, Denmark
        • Roskilde Sygehus
  • France
      • Avignon, France
        • Clinique Rhône Durance
      • Brest, France
        • Hôpital de la Cavale blanche
      • Bron, France
        • Hopital Cardiovasculaire et Pneumologique Louis Pradel
      • Caen, France
        • CHU Côte de Nacre
      • Chesnay, France
        • CMC Parly II
      • Creteil, France
        • Centre Hospitalier Henri Mondor
      • Lille, France
        • Polyclinique de Bois Bernard
      • Marignane, France
        • Clinique Générale
      • Marseille, France
        • Centre Hospitalier Privé Beauregard
      • Massy, France
        • Institut Hospitalier Jacques Cartier
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Ollioules, France
        • Polyclinique Les Fleurs
      • Rouen, France
        • Clinique Saint-Hilaire
      • Toulouse, France
        • Hôpital de Rangueil - CHU
  • Germany
      • Berlin, Germany
        • Vivantes Klinikum im Friedrichshain
  • Ireland
      • Dublin, Ireland
        • St. James's Hospital
      • Dublin, Ireland
        • Mater Misericordiae
  • Jordan
      • Amman, Jordan
        • The Jordan Cardiovascular Center
  • Latvia
      • Riga, Latvia
        • P. Stradins University Hospital
  • Lithuania
      • Kaunas, Lithuania
        • Kaunas Univeristy Hospital
  • Morocco
      • Rabat, Morocco
        • Clinique Agdal
      • Rabat, Morocco
        • Hôpital Militaire d'instruction Mohamed-V
  • Poland
      • Poznan, Poland
        • Szpital im. J. Strusia
      • Poznan, Poland
        • Szpital im. Karola Marcinkowskiego
  • Portugal
      • Evora, Portugal
        • Hospital do Espirito Santo
  • Russian Federation
      • Moscow, Russian Federation
        • Moscow City Hospital
      • St Petersburg, Russian Federation
        • St Petersburg
  • Spain
      • Alicante, Spain
        • Hospital San Juan de Alicante
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Cartagena, Spain
        • Hospital Santa Maria del Rosell
      • Galdakao, Spain
        • Hospital de Galdácano
      • Murcia, Spain
        • Hospital Universitario Virgen de La Arrixaca
      • Salamanca, Spain
        • Salamanca Hospital
      • Santiago, Spain
        • Hospital Clínico Universitario Santiago
      • Valencia, Spain
        • Hospital General de Valencia
      • Valencia, Spain
        • Hospital Dr Pesset
  • Switzerland
      • Fribourg, Switzerland
        • Hôpital Cantonal de Fribourg
      • St. Gallen, Switzerland
        • Kantonsspital St.Gallen
      • Zürich, Switzerland
        • Universitätsspital Zürich
      • Zürich, Switzerland
        • Triemli Stadtspital
    • Geneva
      • Meyrin, Geneva, Switzerland, 1217
        • Hôpital de la Tour
  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital Bath
      • Belfast, United Kingdom
        • Belfast Health and Social Care TRUST,
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Brighton, United Kingdom
        • Brighton and Sussex University Hospitals
      • Bristol, United Kingdom
        • Frenchay Hospital
      • Cambridge, United Kingdom
        • Papworth Hospital
      • Craigavon, United Kingdom
        • Craigavon Cardiac Center
      • Dorchester, United Kingdom
        • Dorset Country Hospital
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • Glasgow, United Kingdom
        • Hairmyres Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • London, United Kingdom
        • King's College
      • London, United Kingdom
        • Lister Hospital, London
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Plymouth, United Kingdom
        • Plymouth Hospitals NHS Trust
      • Portsmouth, United Kingdom
        • Queen Alexandra, Portsmouth
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust
      • Wolverhampton, United Kingdom
        • Royal Wolverhampton Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

"Real world, all comer" patients

Description

Inclusion Criteria:

  1. Age ≥18 years
  2. Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
  3. Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents
  4. No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
  3. Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
  4. Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 12 months
Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 12 months.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
stent thrombosis
Time Frame: 30 days, 6 and 12 months, 2, 3 and 5 years
Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years;
30 days, 6 and 12 months, 2, 3 and 5 years
MACE
Time Frame: 30 days, 6 months, 2, 3 and 5 years;
Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 30 days, 6 months, 2, 3 and 5 years;
30 days, 6 months, 2, 3 and 5 years;
Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization at 30 days, 6 and 12 months, 2, 3 and 5 years;
Time Frame: 6 and 12 months, 2, 3 and 5 years
6 and 12 months, 2, 3 and 5 years
Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;
Time Frame: 30 days, 6 and 12 months, 2, 3 and 5 years;
30 days, 6 and 12 months, 2, 3 and 5 years;
Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;
Time Frame: 30 days, 6 and 12 months, 2, 3 and 5 years
30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.
Time Frame: 30 days, 6 and 12 months, 2, 3 and 5 years.
30 days, 6 and 12 months, 2, 3 and 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosensors Europe SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07EU02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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